B2844 - Industrial Manufacturing and Regulation of Medicines

Learning outcomes

At the end of the course the student - acquires basic knowledge relating to the organizational structure of the pharmaceutical industry in relation to the characteristics of the company; - has in-depth knowledge of the industrial processes for the production of sterile and non-sterile medicines; - will be able to critically address and overcome the various problems that arise in all phases of medicinal product manufacturing; - acquires fundamental notions relating to the regulatory aspects of the production and marketing of industrial medicines, such as GMP, European legislation for placing on the market and the main ICH guidelines; - correctly uses the technical and regulatory language relating to the industrial manufacturing of medicines.

Course contents

Part 1 (prof. Beatrice Albertini ) (48h)

- Pharmaceutical industry: organization, facilities and manufacturing activities.

- Water for pharmaceutical use.

- Production of liquid dosage forms: stirrers, mixers, homogenizers, filters.

- Manufacturing of sterile liquid dosage forms: bottle washing machine, vial washing machine, liquid-filling machine, specific requirements according to cGMP Annex1: processing and monitoring systems. Personnel.

- Freeze-drying: theory and equipment

- Sterilization: theory and equipments for heat sterilization and gamma sterilization.

- Production of solid dosage forms: milling, sieving, mixing, granulation, pellettization, drying, tableting, capsule filling, coating.

- Production of aerosol and inhaler devices

- Manufacturing of semi-solid dosage forms: equipments, process variables.

- Transdermal patches

- Packaging

Part 2 (prof. Nadia Passerini) (16h)

- Structure and organization of the pharmaceutical industry.

- General overview of the European Union pharmaceutical legislation concerning medicinal products for human use; Good Manufacturing Practice; procedures for Marketing authorisation, the Common Technical Document.

- Preformulative and formulative studies

- Stability studies: stability of a drug product; ICH/CPMP guidelines for stability tests (long-term, accelerated and stress studies).

- The concept of validation for the pharmaceutical industry.

- Technology Trasfer and Process Analytical technologies (PAT)

Readings/Bibliography

• La Fabbricazione Industriale dei Medicinali. L. Fabris, A. Rigamonti. Società Editrice Esculapio

• Principi di Tecnologie Farmaceutiche. P. Colombo et al., Casa Editrice Ambrosiana.

 

 Annex 1 of cGMP

Teaching methods

Lectures

Assessment methods

The examination aims to verify the achievement of the necessary skills to perform the professional activity in the pharmaceutical industry. In particular we examine:
• An understanding of the fundamental aspects related to the development and formulation processes of industrial production of medicines
• Knowledge of EU legislation concerning the manufacture, quality assurance of medicines
• The ability to use the above knowledge in order to understand and overcome the problems of formulation and manufacturing of medicines from industrial sources.
The exam takes place only through the final exam, which consists of an oral interview.

Teaching tools

Material: the material presented in class will be available to the student in electronic format through the web site: https://virtuale.unibo.it/

Office hours

See the website of Beatrice Albertini

See the website of Nadia Passerini